Apparatus and methods for developing an anatomic space for laparoscopic hernia repair and patch for use therewith

ABSTRACT

Laparoscopic apparatus and method for insertion into a space or potential space in a body comprising an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is provided and is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A tunneling member is mounted on the distal extremity of the tunneling shaft. A balloon assembly is provided which is removably secured to the tunneling shaft. The balloon assembly includes a balloon wrapped about said tunneling shaft. A sheath is provided which encloses the balloon on the tunneling shaft. The sheath has a slit extending longitudinally thereof permitting the sheath to be removed whereby the balloon can be released and inflated. A tubular member is provided which has a balloon inflation lumen thereon and is coupled to the balloon for inflating said balloon.

[0001] This invention relates to an apparatus and method for developingan anatomic space for laparoscopic hernia repair and a patch for usetherewith.

[0002] In the past, in developing spaces and potential spaces within abody, blunt dissectors or soft-tipped dissectors have been utilized tocreate a dissected space which is parallel to the plane in which thedissectors are introduced into the body tissue. This often may be in anundesired plane, which can lead to bleeding which may obscure the fieldand make it difficult to identify the body structures. In utilizing suchapparatus and methods, attempts have been made to develop anatomicspaces in the anterior, posterior or lateral to the peritoneum. The sameis true for plural spaces and other anatomic spaces. Procedures thathave been performed in such spaces include varocele dissection, lymphnode dissection, sympathectomy and hernia repair. In the past, theinguinal hernia repair has principally been accomplished by the use ofan open procedure which involves an incision in the groin to expose thedefect in the inguinal floor, remove the hernial sac and subsequentlysuture the ligaments and fascias together to reinforce the weakness inthe abdominal wall. Recently, laparoscopic hernia repairs have beenattempted by inserting laparoscopic instruments into the abdominalcavity through the peritoneum and then placing a mesh to cover thehernia defect. Hernia repair using this procedure has a number ofdisadvantages, principally because the mesh used for hernia repair is indirect contact with the structures in the abdominal cavity, as forexample the intestines, so that there is a tendency for adhesions toform in between these structures. Such adhesions are known to beresponsible for certain occasionally serious complications. Such aprocedure is also undesirable because typically the patch is stapledinto the peritoneum, which is a very thin unstable layer covering theinner abdomen. Thus, the stapled patch can tear away from the peritoneumor shift its position. Other laparoscopic approaches involve cuttingaway the peritoneum and stapling it closed. This is time consuming andinvolves the risk of inadvertent cutting of important anatomicstructures. In addition, such a procedure is undesirable because itrequires the use of a general anesthesia. There is therefore a need fora new and improved apparatus and method for developing an anatomic spaceand particularly for accomplishing hernia repair by laparoscopy.

[0003] In general, it is an object of the present invention to providean apparatus and method for developing an anatomic space.

[0004] Another object of the invention is to provide an apparatus andmethod in which such an anatomic space is developed by applyingperpendicular forces to create the anatomic space at the weakest planeto create a more natural, less traumatic and bloodless region in whichto work.

[0005] Another object of the invention is to provide an apparatus andmethod to obtain surgical exposure in the preperitoneal space.

[0006] Another object of the present invention is to provide anapparatus and method of the above character for developing an anatomicspace for laparoscopic hernia repair through the anatomic space.

[0007] Another object of the invention is to provide an apparatus andmethod for decreasing the time and risk associated with creating apreperitoneal working space.

[0008] Another object of the present invention is to provide anapparatus and method of the above character for developing an anatomicspace for laparoscopic hernia repair through the anatomic space.

[0009] Another object of the invention is to provide an apparatus andmethod of the above character which requires a minimally invasiveprocedure.

[0010] Another object of the invention is to provide an apparatus andmethod of the above character which can be accomplished without the useof a general anesthesia.

[0011] Another object of the invention is to provide an apparatus andmethod of the above character which can be accomplished with a spinal orepidural anesthesia.

[0012] Another object of the invention is to provide an apparatus andmethod of the above character which provides substantially reducedmedical costs and a greatly reduced patient recovery time.

[0013] Another object of the invention is to provide an apparatus of theabove character which is relatively simple and compact.

[0014] Another object of the invention is to provide an apparatus andmethod of the above character which can be readily utilized by surgeons.

[0015] Another object of the invention is to provide a patch for use inthe apparatus which is firmly secured during the hernia repair.

[0016] Additional objects and features of the invention will appear fromthe following description in which the preferred embodiments are setforth in detail in conjunction with the accompanying drawings.

[0017]FIG. 1 is a side elevational view partially in cross-section of alaparoscopic apparatus incorporating the present invention.

[0018]FIG. 2 is a cross-sectional view taken along the 2-2 of FIG. 1.

[0019]FIG. 3 is a side elevational view partially in cross-section ofthe tunneling shaft forming a part of the apparatus shown in FIG. 1after it has been removed from the apparatus shown in FIG. 1.

[0020]FIG. 4 is a cross-sectional view taken along the line 4-4 of FIG.3.

[0021]FIG. 5 is an isometric view of the inflatable balloon utilized inthe apparatus in FIG. 1 secured to the tunneling rod.

[0022]FIG. 6 is a cross-sectional view taken along the line 6-6 of FIG.5, and showing by dotted lines the manner in which the balloon as itunfolds develops the anatomic space.

[0023]FIG. 7 is a partial plan view of a prone human body, showing thelower abdomen showing the manner in which the laparoscopic apparatus ofthe present invention is utilized for performing a hernia repair throughthe preperitoneal space.

[0024]FIG. 8 is a sagittal view of the lower abdominal cavity of thehuman being shown in FIG. 7 showing the apparatus of the presentinvention introduced into the preperitoneal space.

[0025]FIG. 9 is a view similar to FIG. 8 but showing the sleeve removedfrom the apparatus and with the balloon inflated.

[0026]FIG. 10 is a sagittal view similar to FIG. 8 showing the balloondeflated and being removed.

[0027]FIG. 11 is a sagittal view similar to FIG. 8 showing removal ofthe tunnelling shaft.

[0028]FIG. 12 is an isometric view of a patch incorporating the presentinvention.

[0029]FIG. 13 is a side elevational view of the patch shown in FIG. 12.

[0030]FIG. 14 is an isometric view showing the patch in FIGS. 12 and 13in a rolled-up, generally cylindrical configuration.

[0031]FIG. 15 is a sagittal view showing the hernia sac of hernia thatis to be repaired.

[0032]FIG. 16 is a sagittal view showing the introducer through whichthe rolled-up patch in FIG. 17 has been introduced into thepreperitoneal space by an introducer rod.

[0033]FIG. 17 is a sagittal view similar to FIG. 16 showing theattachment of the patch to the hernia sac.

[0034]FIG. 18 is a sagittal view similar to FIG. 17 showing thedissection of the hernia sac and the unrolling of the patch.

[0035]FIG. 19 is a sagittal view showing the patch in place to providethe hernia repair.

[0036]FIG. 20 is an isometric view of another embodiment of a balloonwith a patch disposed thereon for use with the apparatus of the presentinvention.

[0037]FIG. 21 is a cross-sectional view taken along the line 21-21 ofFIG. 20.

[0038]FIG. 22 is an enlarged cross-sectional view taken along the line22-22 of FIG. 23.

[0039]FIG. 23 is a sagittal view showing the manner in which the balloonand patch shown in FIG. 20 are disposed in the preperitoneal space.

[0040]FIG. 24 is a sagittal view showing the placement of the balloonand the patch of FIG. 20, and the inflation of the balloon in thepreperitoneal space.

[0041]FIG. 25 is an isometric view of another embodiment of a balloonand patch for use with the apparatus of the present invention.

[0042]FIG. 26 is a rolled-up cross-sectional view of the balloon andpatch shown in FIG. 25.

[0043]FIG. 27 is an isometric view of another embodiment of a patch foruse with the apparatus of the present invention.

[0044]FIG. 28 is an isometric view of the patch shown in FIG. 27 wrappedin an introducer assembly.

[0045]FIG. 29 is a top plan view of another embodiment of a laparoscopicapparatus incorporating the present invention.

[0046]FIG. 30 is a side elevational view taken along the line 30-30 ofFIG. 29.

[0047]FIG. 31 is a cross-sectional view taken along the line 31-31 ofFIG. 30.

[0048]FIG. 32 is a cross-sectional view taken along the line 32-32 ofFIG. 30.

[0049]FIG. 33 is an enlarged cross-sectional view of the distalextremity of the laparoscopic apparatus shown in FIG. 29.

[0050]FIG. 34 is a partial plan view showing the balloon after it hasbeen removed from the laparoscopic apparatus with the obturator tipshifting its position.

[0051]FIG. 35 is a plan view of the balloon shown in FIG. 34 as it isbeing removed from the body of the patient and bringing along with itthe obturator tip.

[0052]FIG. 36 is a side elevational view of another embodiment of alaparoscopic apparatus incorporating the present invention.

[0053]FIG. 37 is a plan view showing the balloon from the apparatusshown in FIG. 36 in an inflated condition and showing the tunneling rodmounted therein being prevented from being advanced beyond the distalextremity of the balloon.

[0054]FIG. 38 is a plan view showing the manner in which the balloon isseparated from the tunneling rod as it is retracted.

[0055] In general, the apparatus of the present invention is used forinsertion into a body to create an anatomic space. The apparatus iscomprised of a tubular introducer member having a bore extendingtherethrough. A tunneling shaft is slidably mounted in the bore and hasproximal and distal extremities including a bullet-shaped tip. A roundedtunneling member is mounted on the distal extremity of the tunnelingshaft. An inflatable balloon is provided. Means is provided on theballoon for removably securing the balloon to the tunneling shaft. Meansis also provided for forming a balloon inflation lumen for inflating theballoon. The balloon is wrapped on the tunneling shaft. A sleevesubstantially encloses the balloon and is carried by the tunnelingshaft. The sleeve is provided with a weakened region extendinglongitudinally thereof, permitting the sleeve to be removed whereby theballoon can be unwrapped and inflated so that it lies generally in aplane. The balloon as it is being inflated creates forces generallyperpendicular to the plane of the balloon to cause pulling apart of thetissue along a natural plane to provide the anatomic space.

[0056] More in particular, as shown in the drawings, the apparatus ordevice 31 for creating such an anatomic space for use in a laparoscopicprocedure (see FIG. 1) includes an introducer sleeve or device 32 whichconsists of a tubular member 33 formed of a suitable material such asplastic which is provided with a bore 34 extending throughout the lengththereof. A handle section 36 is mounted on one end of the tubular member33 and is also formed of a suitable material such as plastic. It isprovided with a bore 37 which is in communication with the bore 33. Aflapper valve 38 is mounted within the section 36 and is movable betweena position in which it closes off the bore 37 and position out of theway of the bore 37, by means of a finger operated actuator 39 mounted onthe exterior of the section 36. A stopcock 41 is mounted on the section36 and is in communication with the passage 37. A lever 42 is providedfor opening and closing the stopcock 41.

[0057] A tunneling shaft assembly 46 is slidably mounted in the bores 37and 34 of the introducer sleeve 32. The tunneling shaft assembly 46consists of a tunneling shaft or rod 47 formed of a suitable materialsuch as stainless steel, of a suitable length, as for example ⅛ inches,and a suitable diameter of approximately ⅛ inch. The tunneling rod 47 isprovided with proximal and distal extremities 48 and 49.

[0058] An introducer member 51 is slidably mounted on the tunnelingshaft or rod 47 and is formed of a suitable material such as plastic.The introducer member 51 is substantially hollow as shown and isprovided with a bore 52 through which the tunneling shaft 47 extends.The introducer member 51 is provided with a substantially hemisphericaltip 53 to form a rounded protrusion or first obturator through which therod 47 extends. The introducer member 51 has a length such that when itis introduced into the bore 34 of the introducer sleeve, it extends outof the distal extremity of the introducer sleeve 32, as shownparticularly in FIG. 1. This diameter of the introducer member 51 issized so that it can be slidably mounted in the bore 34. The other endof the introducer member 51 is provided with a chamfer 54.

[0059] A disk-type seal 43 having a central opening is provided in thesection 36 in alignment with the bore 37, and is adapted to permit theintroduction of the introducer member 51 therethrough.

[0060] The section 36 forms one part of a three-piece handle 56 of thelaparoscopic apparatus 31 which is sized so that it is adapted to begrasped by the human hand. As can be seen particularly in FIG. 4, thehandle 56 is generally rectangular in cross-section. The handle 56 isprovided with an intermediate section 57 which has a bore 58 extendingtherethrough in registration with the bore 37 and has the same generaldiameter as the bore 37 so that the introducer member 51 can traveltherethrough. The sections of the handle 56 can be characterized ashaving first, second and third sections, in which section 36 is thefirst section and intermediate section 57 is the second section.Latching means is provided for interconnecting the intermediate section57 to the end section 36, and consists of a pair of oppositely disposedlatches 61 pivotally mounted on the pins 62 in the intermediate section57. Each of the latches 61 is provided with a latch portion 63 adaptedto engage a protrusion 64 provided on the end section 36, and isyieldably urged into engagement therewith by a spring 66. Each of thelatches is provided with a cam surface 67 which is adapted to be engagedby the chamfer 54 of the introducer member 51 to cam the latch portion63 out of engagement with the protrusion 64 to release the intermediatesection 57 from the end section 36 for a purpose hereinafter described.

[0061] The handle 56 also consists of another end section 71, which canalso be characterized as the third section, which is secured to theproximal extremity of the tunneling shaft or rod 47. A pair of latches72 are provided in the end section 71 and are pivotally mounted on pins73. The latches 72 are provided with latch portions 74 adapted to engageprojections 76 provided in the intermediate section 57. Means isprovided for yieldably retaining the latches 72 in engagement with theprojections 76 and consists of a U-shaped spring 77 mounted within theend section 71 and engaging the latches 72. The latches 72 are providedwith knurled portions 72 a which extend outwardly which are adapted tobe grasped by the fingers of the hand so that the latch portions 74 canbe moved out of engagement with the projections 76 against the force ofthe spring 77.

[0062] The tunneling shaft assembly 46 also includes a tunneling memberor tip 79 which is mounted on the distal extremity of the tunnelingshaft or rod 47. As shown, the tip 79 is substantially olive-shaped andcan also be called a second obturator. It is provided with a roundedhemispherical surface on its distal extremity which has a maximumdiameter which is slightly less than the diameter of the bores 34 and 37so that it can pass through the introducer sleeve 32. The proximalextremity of the tip 79 is of smaller diameter to provide an annularstep 81 in the tip. The proximal extremity of the tip 79 is alsohemispherical, as shown. The tunneling member or tip 79 can be formed ofa suitable material such as plastic and can be secured to the distalextremity of the tunneling shaft or rod 47 by suitable means such as anadhesive. As hereinafter explained, the tunneling shaft or rod 47 ismovable so that the tip 79 can be brought into engagement with thehemispherical end 53 of the introducer member 51 for a purposehereinafter described.

[0063] The laparoscopic apparatus 31 also includes a balloon assembly 86which is shown in FIGS. 2, 5 and 6. As shown in FIG. 5, when the balloonassembly 86 consists of a balloon 87 which in plan, when deflated, has apear-shaped configuration. The balloon is preferably formed of anon-elastomeric, medical-grade material of a suitable type such as PVC.Thus, the balloon 87 can be formed of two sheets 88 and 89 of such amaterial which have their outer margins bonded together by suitablemeans such as by a heat seal 91 extending around the perimeter of theflat balloon 87. The balloon 87 is provided with a neck 94 into which aflexible tubular member 96 extends, and is secured therein in a suitableairtight fashion such as by an adhesive. The tubular member 96 isprovided with a lumen 97 which is in communication with the interior ofthe balloon and which can be used for inflating the balloon through aLuer-type fitting 98 mounted on the free end of the tubular member 96.

[0064] Means is provided for removably securing the balloon 87 to thetunneling rod or shaft 47, and consists of a sleeve 101 formed of thesame material as the balloon 87, and which can be formed integral orseparate therefrom and adhered thereto by suitable means such as anadhesive. The sleeve 101 extends longitudinally of the balloon 87 and isdisposed generally equidistant from the side margins of the same. Thesleeve 101 is provided with a passage 102 extending therethrough whichis sized to slidably accommodate the tunneling shaft or rod 47. Means isprovided for permitting separation of the balloon 87 from the tunnelingrod by movement sidewise from the axis of the passage 102 and takes theform of longitudinally spaced apart perforations 103 in the sleeve 101extending longitudinally the length of the sleeve 101. The perforations103 are spaced close enough together to form a weakened region so thatthe balloon can be readily separated from the tunneling rod byseparating the plastic sleeve 101 by tearing the plastic between theperforations as hereinafter described.

[0065] As shown in FIG. 6, the sleeve 101 is disposed equidistant fromthe side margins of the balloon, permitting the balloon to be inflatedas hereinafter described and as also shown by the dotted lines in FIG.6, to be inflated around the rod 47. When deflated, the side margins ofthe balloon 87 can be rolled inwardly toward the rod 47 as shown by thebroken lines in FIG. 6 to permit the same to be folded into a generallycylindrical configuration as shown in FIG. 2, and to be enclosed withina removable sleeve 106 carried by the tunneling shaft or rod 47. Theremovable sleeve 106 is formed of a relatively thin-walled tubularmember 107 of a suitable material such as Teflon which has a weakenedregion 108 in its wall extending longitudinally the length thereof. Thisweakened region 108 can take the form of a slit as shown, or can be aseries of perforations or slots formed in the wall, or a combinationthereof. The proximal extremity of the tubular member 107 is providedwith split-apart or separable end portions 107 a and 107 b to which aresecured finger rings 109 of a suitable material such as plastic andsecured thereto by fasteners 111.

[0066] Operation and use of the laparoscopic apparatus in performing themethod for laparoscopic hernia repair through preperitoneal space maynow be briefly described as follows. Let it be assumed that thelaparoscopic apparatus 31 has been assembled as shown in FIG. 1. Asshown in FIG. 7, let it be assumed that a human patient 121 is in aprone position and has a hernia 122 in the lower abdominal area which hewishes to have repaired. The patient is prepared in an appropriatemanner by administering a suitable anesthesia, as for example a spinalanesthesia, and any other necessary preparation. The surgeon first makesan infraumbilical incision 126 in the skin below the navel or umbilicus127 and separates the fat 129 and then incises the anterior rectussheath or fascia 131 in the midline. Care should be taken not topenetrate the peritoneum overlying the abdominal cavity 133 (see FIG.8).

[0067] After the incision 126 has been made in the manner hereinbeforedescribed, the laparoscopic apparatus 31 is then taken by one hand ofthe surgeon, grasping the handle 56 and utilizing the other hand tofacilitate the insertion of the rounded blunt tip 79 into the incision126. The blunt tip 79 is caused to enter the slit in the fascia 131 andpass anterior to the peritoneum 132, in between the rectus muscles(laterally), and enters the potential preperitoneal space 136 to beprovided for the laparoscopic procedure. The blunt tip 79 is thenutilized as a tunneling device by the surgeon using one hand 56 toadvance the blunt end 79 toward the pubic region of the patient whilethe surgeon places his other hand on the abdomen to feel the apparatusor device 31 as it is being advanced. The advance of the device 31 iscontinued until the blunt tip 79 is below the symphysis pubis 137 asshown in FIG. 8, and preferably is disposed between the symphysis pubis137 and the bladder 138.

[0068] After the apparatus or device 31 has been properly positioned asshown in FIG. 8, the removable sleeve or sheath 106 is removed by thesurgeon using one hand to engage the finger rings 109 which are exteriorof the body of the patient and outside of the incision 126. At the sametime, the other hand of the surgeon is utilized to stabilize the portionof the device 31 which is within the preperitoneal space. The sheath 106can be readily withdrawn since it is formed of Teflon and is split orweakened along its length, by pulling it proximally and away from thelongitudinal axis of the tubular member 33. As the sheath 106 opens andslips off, it exposes the balloon 87 of the balloon assembly 86. Whenthe sheath 106 is completely removed, a sterile saline solution servingas a balloon inflation medium is introduced into the balloon 87 throughthe tubular member 96 by connecting a conventional syringe 141 to theLuer fitting 98. The balloon 87 typically can be inflated to a suitablesize by introducing 500 cc or less of normal saline solution into theballoon by pressing on the plunger 142. As the balloon 87 is inflated,the balloon progressively unwraps with its side margins rollingoutwardly from the center while expanding into a plane to causeprogressive separation or dissection of tissue (i.e. 131, 132) along itsweakest points by application of forces generally perpendicular to theplane of the balloon as indicated by the arrows 143 in FIGS. 6 and 9, tocreate the preperitoneal or anatomic space. The balloon 87 expandsaround the tunneling shaft 47 in the manner shown in broken lines inFIG. 6 to achieve the progressive separation until complete inflation isachieved. The surgeon can sense the filling of the balloon by feelingthe abdomen of the patient as the balloon is inflated. The balloon 87serves to open up the preperitoneal space 136 to provide a bloodlessspace for the procedures hereinafter to be performed. Since the balloonis formed of a non-elastomeric material, it is a volume-limited balloonto prevent overexpansion. Different sizes of balloons can be utilizedfor different patient sizes. With a smaller balloon it is possible todeflate the balloon and then shift the balloon and again reinflate it toobtain the desired bloodless preperitoneal space.

[0069] After the desired bloodless anatomic space or pocket 136 isformed, the balloon 87 is deflated by withdrawing the normal salinesolution by withdrawal of the plunger 142 of the syringe 141 or via ahospital vacuum aspirator. After the balloon 87 has been deflated, theballoon assembly 86 can be removed by grasping the handle 56 of thelaparoscopic apparatus or device 31 with one hand and using the otherhand to grasp the tubular member 96 and the proximal extremity of theballoon 87 and to remove the same through the incision 126, as shown inFIG. 10. As the balloon 87 is being removed, it is progressivelyseparated from the tunneling rod or shaft 47 by causing the sleeve 101to split apart along the longitudinal perforations 103 provided in thesleeve 101. This makes it possible to separate the balloon 87 from thetunneling rod 47 without the necessity of removing the tunneling rod 47or the introducer device 32.

[0070] After the balloon assembly 86 has been removed, the introducerdevice 32 can be advanced distally over the tunneling shaft or rod 47 soit extends well into the preperitoneal space 36 as shown in FIG. 11. Theend section 71 of the handle 56 is then removed by depressing thelatches 72 by having the fingers engage the portions 72 a to disengagethe latch portions 74 from the intermediate section 57 of the handle 56.The end section 71 is then drawn proximally as shown in FIG. 11 to bringthe olive-shaped tip 79 into engagement with the obturator 53 disposedin the distal extremity of the tubular member 33 to cause both the tip79 and the obturator 53 to be withdrawn or retracted. As the introducermember 51 is being withdrawn, its chamfer 54 will strike the camsurfaces 67 of the latches 61 to cause them to disengage from the endpiece 36 to carry it along with the introducer member 51 and shown inFIG. 2. Thus, it can be seen that the tunneling shaft assembly 46 can bereadily removed merely by one motion of the surgeon's hand. Thereafter,a conventional laparoscope 144 (see FIG. 16) can be introduced throughthe introducer sleeve 32 to permit the surgeon to view the preperitonealspace 136.

[0071] The dissected preperitoneal space 136 is then insufflated withcarbon dioxide through the stopcock 41 to a pressure ranging from 6 to 8mm of mercury. Thereafter, two additional trocars 146 and 147 areintroduced through the abdominal wall into the dissected preperitonealspace 136 in appropriate locations. Thus, as shown in FIG. 7, trocar 146is introduced into the left side of the abdomen of the patient below theintroducer sleeve 32 and the trocar 147 is introduced into the dissectedpreperitoneal space immediately above the symphysis pubis and directlybelow the introducer sleeve 32. As can be appreciated, the locations ofthe trocars 146 and 147 is generally dictated by the location of thehernia 122 to be repaired.

[0072] A patch 151 of the present invention to be utilized in the herniarepair procedure is shown in detail in FIGS. 12, 13 and 14. The patch151 can be characterized as a hernia patch or graft and is made of asuitable plastic mesh such as a Prolene mesh manufactured by Ethicon,Inc. The patch 151 can be of any desired configuration. For example itcan be generally circular as shown, and consists of a disk 152 of asuitable diameter, as for example 2 inches. A tail 153 is secured to thedisk substantially in the center thereof, in a suitable manner. Forexample, as shown, the tail 153 can be provided with split portions 153a and 153 b which are split apart and offset with respect to each other,which are secured to a smaller reinforcing disk 154 formed of the samematerial as disk 152 and secured to the disk 152 by suitable means suchas surgical thread (not shown). The tail 153 is formed of the samematerial as the disk 152 and 154, or it can be formed of a differentmaterial, such as Goretex. It can have a size such that it has a widthof approximately ½ inch and a length of approximately 1 ½ inches. Asshown particularly in FIG. 14, the side margins of the disk 152 can berolled inwardly towards the center adjacent the tail 153 to form acylindrical roll 156 such as shown in FIG. 14 with the tail 153extending outwardly therefrom. The roll 156 can be maintained in itsrolled-up condition by means of sutures 157 disposed adjacent oppositeends of the roll and on opposite sides of the tail 153.

[0073] Conventional laparoscopic instruments are utilized which areintroduced through the trocars 146 and 147 while visualizing the samethrough the laparoscope 144 introduced through the introducer device 32to dissect the hernia 161 to permit visualization of its neck 162 as itis entering the internal inguinal ring 163. The hernia sac 161 isdissected from the surrounding tissue (spermatic duct and vessels) (seeFIG. 15). The process is facilitated by CO₂ pressure impinging on theneck of the hernia sac. As soon as this dissection is completed, theroll 156 is pushed into the trocar 147 and advanced through the same bysuitable means such as a deployment rod 164 (see FIG. 16) to enter thedissected preperitoneal space 13 as shown in FIG. 16. Alternatively, theroll 156 can be placed in a tubular member (not shown) which can be usedto position the roll 156 within the trocar 157. Thereafter, by thedeployment rod 164, the roll 156 can be pushed out of the tubular memberinto the dissected preperitoneal space 136.

[0074] The roll 156 after it is in the preperitoneal space is thenmanipulated so that its tail 153 is disposed alongside the neck 162 ofthe hernia sac 161 as shown in FIG. 17. A conventional stapling device166 is then introduced through the trocar 146 to staple the tail 153 tothe neck 162 by placing staples 167 therein. These staples 167 serve todivide the neck of the sac into distal and proximal portions 162 a and162 b. As soon as this stapling operation is completed, the two portions162 a and 162 b are separated from each other because of the pressure ofthe insufflation gas to cause the tail 153 of the patch 151 to be pulledupwardly into the inguinal ring to pull with it the disk 152. Thesutures 157 are cut apart to permit the disk 152 to unroll and to beplaced across the inguinal ring 163 which created the main weakness inthe abdominal wall permitting the hernia which is being repaired tooccur. The proximal portion 162 b of the neck 162 is stapled together bystaples 173 as shown in FIG. 18. The proximal portion 162 is thenpermitted to fold back into the desired anatomical location within theabdomen.

[0075] Thereafter, while observing the procedure under the laparoscope,the dissected preperitoneal space 136 can be deflated by permitting thecarbon dioxide gas to escape to the atmosphere through the stopcock 41in the introducer device 32 by operation of the stopcock lever arm 42.As deflation is taking place, the movement of the patch 151 is observedthrough the laparoscope 144 so that it does not become misplaced. Whenthe deflation has been completed, the patch 151 is in a position overthe inguinal ring 163 and serves to provide enforcement to prevent theoccurrence of another hernia in that area. The tail 153 is disposed withthe inguinal ring 163 and retains the mesh disk 152 so that it surroundsthe inguinal ring 163.

[0076] After deflation has been accomplished, the trocars 146 and 147 aswell as the introducer device 32 can be removed. Small sutures can thenbe utilized to close the various small openings which have been providedin the abdominal wall so that upon healing there will be minimalnoticeable scars from the procedure. The scar in the navel or umbilicustypically is almost nearly invisible.

[0077] It has been found that the use of the laparoscopic apparatus 31in accomplishing the method as hereinbefore set forth provides aprocedure in which the pain after the operation is markedly reduced.This is particularly true since the operation does not involve suturingof any ligaments which typically produces the pain. In addition, therecovery time for the patient is greatly accelerated. In the procedureof the present invention, a patient can return to work within a matterof 3 to 5 days rather than in a number of weeks as in a conventionalhernia repair procedure. The procedure also has other advantages. Forexample, there is a lack of necessity for a general anesthesia. Anotherprincipal advantage of the procedure is there is no contact of meshpatch 151 with the intestines of the patient or other intra-abdominalstructures, thus greatly reducing the possibility of adhesion formation.In addition, the graft which is formed by the patch 151 is more secureand is positioned in an anatomically correct position. This is becausethe hernia sac is in exact alignment with the hernia and pulls with itthe tail 153 of the graft to ensure that the graft formed by the patch151 is drawn into the correct position and is maintained in thatposition to prevent migration. In addition, the graft, by having anadditional central disk 154, ensures that additional reinforcement isprovided in the proper location in the center where the weakest regionin the abdominal wall has occurred. In addition, by such propercentering, the mesh construction of the patch 151 serves to uniformlyreinforce the area surrounding the hernia.

[0078] Another embodiment of the present invention is shown in FIGS. 20,21 and 22 with respect to another embodiment of a balloon assembly 181and another embodiment of a patch or graft 182. The balloon assembly 181consists of a balloon 186 formed of two sheets 187 and 188 which arerectangular in shape, as for example square as shown in FIG. 20, whichare heat-sealed together at their outer margins as indicated by thebroken line 189. A tubular member 191 is provided which has one endsealed into one corner of the balloon 186 as shown in FIG. 20. Thetubular member 191 is provided with a lumen 192 which opens up into theinterior space 193 of the balloon. The sheets 187, 188 are formed of anon-elastomeric material of the type hereinbefore described. A Luerfitting 194 is connected into the free end of the tubular member 191 andis utilized for introducing a saline solution into the balloon 186 forinflating the same.

[0079] The graft or patch 182 can have a desired configuration, as forexample circular as shown in FIG. 20. It is formed of a non-absorbablesynthetic surgical mesh, as for example from polypropylene manufacturedby Ethicon Inc. As shown, the mesh patch 182 overlies the sheet 187.

[0080] The balloon assembly 182 with the patch 182 thereon can be rolledup into a roll 196 as shown in FIG. 22 in which the patch or graft 182is disposed within the roll. The roll can be maintained in the rollconfiguration by sutures 197 wrapped about the same. The roll 196 canthen be introduced through a side trocar 146 and introduced into thedissected preperitoneal space 136 with the tubular member 191 extendingthrough the trocar 146 and having its Luer fitting 194 disposed outsideof the trocar. After the roll 196 has been introduced, the sutures 197can be removed and the balloon can be inflated by introducing a salinesolution through the fitting 194 by use of a syringe 199. Before thesaline solution is introduced to inflate the balloon, the roll 196 isproperly positioned so that when it is inflated and begins to unroll itwill unroll in the proper direction so that the graft or patch 182carried thereby is properly positioned as shown in FIG. 23. After theroll 196 has been completely unrolled, continued inflation of theballoon 186 moves the patch 182 so that it is pressed against theportion of the fascia through which the hernia has occurred as shown inFIG. 24. As soon as the graft 182 has been properly positioned, theballoon 186 is deflated. The trocar 146 is then removed, and thereafterthe balloon can be withdrawn through the opening in which the trocar waspresent. Thereafter, the gas utilized for insufflation can be permittedto discharge through another trocar so that the fascia 131 comes intoengagement with the peritoneum 132 with the large-area patch 182 held inplace therebetween. Thereafter, the trocars can be removed in the mannerhereinbefore described to complete the procedure.

[0081] Another embodiment of a balloon assembly for deploying alarge-area patch or graft through a trocar is shown in FIG. 25. Thelarge-area graft 201 shown in FIG. 25 is formed of a mesh material ofthe type hereinbefore described and has a generally oval-shapedconfiguration conforming to the general shape of the balloon 202 of theballoon assembly 203. The balloon 202 is constructed of anon-elastomeric material in the manner hereinbefore described. A tubularmember 206 is provided for inflating the balloon and has a Luer fitting207 on the free end thereof. Means is provided for retaining the meshgraft 201 on one side of the balloon and consists of plastic flaps 208provided on opposite sides of the balloon 202, and secured thereto by asuitable means such as a heat seal along the broken line 209. The innermargins of the flaps 208 are free and are adapted to receive the outermargins of the graft 201 as shown particularly in FIG. 25.

[0082] The balloon 202 with the mesh graft 201 thereon can be rolled upinto a substantially cylindrical roll 211 by rolling the outer marginsof the balloon inwardly on top of the mesh material to provide two rolls211 and 212 which are brought in adjacent to each other as shown in FIG.26 with the mesh graft 201 being wrapped up therewith. The two rolls 211and 212 can then be inserted into a tubular sheath 214. The sheath 214can then be introduced through a trocar in a manner hereinbeforedescribed and then pushed out of the sheath into the abdominal cavity.The balloon can then be inflated with a saline solution to cause the tworolls 211 and 212 to unroll in opposite directions and then for theballoon to inflate to move the patch 201 carried thereby into engagementwith the portion of the fascia having the hernia therein. Thereafter,the balloon can be deflated, the trocar removed, the balloon removed,and the dissected preperitoneal space deflated so that the large meshgraft 201 is disposed between the fascia and the peritoneum and isretained in position therebetween.

[0083] Another embodiment of a graft which can be utilized in connectionwith the present invention is shown in FIG. 27. The patch or graft 216is constructed in a manner similar to the graft or patch 151 shown inFIGS. 12 and 13, with the exception that it is constructed in a mannerso that it can be utilized with a direct hernia rather than an indirectinguinal hernia hereinbefore described. The graft 216 is formed of asheet of circular mesh in the form of a disk 217 with a reinforcingcentral disk 218 which has a barbed head 219 secured thereto. The barbedhead 219 is formed of a biodegradable material such as polyglycolicacid. The mesh graft 216 can be folded over a deployment rod 221 andintroduced into a cylindrical sheath 222 (see FIG. 28) which is sized sothat it can be introduced through a conventional trocar, then deployedfrom the sheath 22 by pushing on the deployment rod 221. After the graft216 has been deployed into the dissected preperitoneal space 136, it canbe positioned in an appropriate manner so that the barb 219 ispositioned so that it is in alignment with the inguinal ring wherebyupon deflation of the preperitoneal space 136, the barb 219 will extendthrough the inguinal ring to serve to retain the graft 201 firmly inplace.

[0084] Another embodiment of a laparoscopic apparatus incorporating thepresent invention is laparoscopic apparatus 231 as shown in FIGS. 29through 32. The laparoscopic apparatus 231 includes introducer sleeve ordevice 32 identical to that hereinbefore described. It also includes atunneling shaft assembly 46 which is provided with a tunneling shaft orrod 47 and a proximal extremity 49 (see FIG. 32). In the previousembodiment of the laparoscopic apparatus, the tunneling shaft assemblyis provided with an olive-shaped or bullet-shaped tip 79 which wassecured to the distal extremity 49 of the tunneling shaft 47. In thepresent embodiment of the apparatus shown in FIGS. 29 through 32, theobturator tip 79 a is detachably mounted on the distal extremity 49 ofthe tunneling rod 47. The proximal extremity of the tip 79 a is providedwith a slot 236 which extends through one side of the proximal extremityinto the central portion of the proximal extremity of the tip 79 a. Theslot 236 is adapted to receive the rounded extremity 237 provided on thedistal extremity 49 of the tunneling rod 47 (see FIG. 32). A removablesleeve 241 is provided as a part of a laparoscopic apparatus 231, and issimilar in many respects to the removable sleeve or sheath 106hereinbefore described. The removable sleeve 241 is formed of a suitablematerial such as Teflon as hereinbefore described and is provided with atubular member 242 which is provided with a relatively thin wall 243that has a weakened portion extending longitudinally thereof in the formof a slit 244 (see FIG. 31). The tubular member 242 is provided with aproximal extremity 246 and a distal extremity 247. The proximalextremity 246 has a thicker cross-section than the distal extremity 247,as shown in FIGS. 31 and 32. The proximal extremity 246 is provided witha recess 248 formed in the wall which is diametrically opposite the slit244 that serves as a relief region to permit the movable sleeve 241 tobe split apart when it is removed from the balloon.

[0085] The proximal extremity 246 is provided with wing-like members 251and 252 which extend diametrically therefrom, spaced 90° apart from theslit 244. These outstretched wings 251 and 252 serve to help thephysician orient the laparoscopic apparatus 231 as it is being utilized.The proximal extremity 246 is also provided with a handle 256 which isformed integral therewith and which extends radially from the tubularmember 242. The handle 256 is provided with a finger hole 257 extendingtherethrough through which a finger can be inserted to facilitatepulling the removable sleeve 241 off of the balloon as described inconnection with the previous embodiment.

[0086] As shown in FIG. 33, the tip 79 a is detachably mounted in theproximal extremity of the removable sleeve 241 so that the tip 79 canserve as a second obturator during introduction of the laparoscopicapparatus 231 as hereinbefore described. Means is provided for securingthe detachable tip 79 a to prevent it from becoming separated from thelaparoscopic apparatus 231 and for permitting its withdrawal after thelaparoscopic procedure is being completed. As shown in FIGS. 33 and 34,such means consists of a flexible elongate element 261 in the form of abraided string formed of a suitable fabric such as Nylon, which has oneend 262 secured in a slot 263 provided on the distal extremity of thetip 79 a by suitable means such as an adhesive (not shown). The flexibleelongate element 261 extends from the distal extremity of the tip 79 ain a recess 264 opening through the external surfaces of the tip 79 a.The proximal extremity of the flexible elongate element 261 can besecured directly to the balloon 87 or, alternatively, it can extendthrough the perforated sleeve 101 provided in the balloon along thetunneling shaft so that it extends beyond the proximal extremity of thetunneling shaft.

[0087] The use of the laparoscopic apparatus 231 in performing alaparoscopic procedure is substantially identical to that hereinbeforedescribed with the exception that when the removable sleeve 241 isremoved from the balloon 87, the removable sleeve can be pushedforwardly to detach the tip 79 a from the tunneling shaft 47. Theremovable sleeve 241 then can be pulled rearwardly to separate it fromthe balloon along the slit 244. As soon as this occurs, the tip 79becomes free of the sleeve and begins to rotate in the direction of thearrow 266 shown in FIG. 34. When the balloon has been inflated and hasperformed its functions as hereinbefore described and it is now desiredto remove the balloon 87, the balloon 87 can be withdrawn in the mannerhereinbefore described, and since the tip 79 a is tethered to theballoon 87 itself or flexible elongate element 261 attached theretoextends out proximally of the balloon 87, the tip 79 a is withdrawn orcan be withdrawn with the balloon 87.

[0088] This laparoscopic apparatus 231 with its detachable obturator tip79 a will be useful in certain applications of the present invention.With the previous laparoscopic apparatus hereinbefore described, thereis a possibility that when the obturator tip 79 is withdrawn, criticalstructures, as for example small arteries, may be inadvertently incisedbetween the tip 79 and the distal extremity of the tubular member 33 ofthe introducer device 32. This possibility is eliminated by having thedetachable tip 79 a, which is withdrawn when the balloon is withdrawn.

[0089] Still another embodiment of the laparoscopic apparatusincorporating the present invention is shown in FIGS. 36, 37 and 38, inwhich the laparoscopic apparatus 271 consists of a balloon 272 of thetype hereinbefore described, which is provided with a perforated sleeve273 through which the tunneling rod 47 extends. The distal extremity 274of the sleeve is closed by an end piece 276. The balloon 272 is wrappedin the manner hereinbefore described around the tunneling shaft 247. Thetunneling shaft or rod 47 is not provided with a tunneling member orsecond obturator of the type hereinbefore described but its end isrounded as shown by providing a rounded tip 47 a.

[0090] The wrapped balloon 272 is enclosed within a removable sleeve 281which is similar to those hereinbefore described. It is provided with atubular member 282 that has a weakened region in the form of a slit 283extending longitudinally the length thereof. The removable sleeve 281differs from those hereinbefore described in that rather than being openat the end as in previous embodiments, it is provided with a closed-end,bullet-shaped or olive-shaped tip 286. The slit 283 is provided with acurved portion 283 a which extends through the bullet-shaped tip 286 sothat the sleeve can be peeled off of the balloon 272 in the mannerhereinbefore described by pulling on the handle 288 having a finger hole289 therein. During the time that the removable sleeve 281 is beingpeeled off or separated from the balloon 272, the balloon is held inplace by the tunneling rod 47 which engages the end 276 of theperforated sleeve 273. The balloon 272 after it is inflated can beseparated from the tunneling rod 47 by pulling on the balloon andcausing its distal extremity to lift up and to break apart at theperforations and peel away from the rounded extremities 47 a of thetunneling shaft 47 as shown in FIG. 38. Continued pulling on the balloon272 will cause it to separate from the tunneling rod 47 so that theballoon 272 can be removed as hereinbefore described. Thus, it can beseen that there has been provided an embodiment of the laparoscopicapparatus of the present invention in which the need for an obturatorcarried by the distal extremity of the tunneling rod 47 has beeneliminated by providing the second obturator as a part of the removablesleeve 281. In all other respects, the operation and use of thelaparoscopic apparatus 271 is similar to that hereinbefore described.

[0091] From the foregoing it can be seen that there has been provided anapparatus and method for developing an anatomic space by the use of awrapped balloon which, as it is inflated, gradually unwraps to tend toform a plane to cause forces to be created perpendicular to the planefor pulling apart tissue along a natural plane to provide an anatomicspace, thereby providing a dissection in the weakest plane creating amore natural, less traumatic and bloodless region in which to performvarious medical procedures. Such anatomic spaces can be created invarious parts of the human body, for example in the preperitoneal areato provide a space anterior to the peritoneum for hernia repair and forvarocele dissection. Spaces can also be developed lateral to theperitoneum and spaces posterior to the peritoneum for performing medicalprocedures such as a sympathectomy and a lymph node dissection.

[0092] As hereinbefore explained, the apparatus and method isparticularly appropriate for performing laparoscopic hernia repair,permitting the use of grafts and patches which can be used for directand indirect hernias with minimal pain to the patient and with thepatient being able to return to work within a few days.

What is claimed is:
 1. In an apparatus for creating an anatomic space intissue in a body, an introducer device having a tubular member with abore extending therethrough, a tunneling shaft assembly slidably mountedin the bore of the introducer device, said tunneling shaft assemblyincluding a tunneling shaft having proximal and distal extremities, aballoon assembly, means carried by the balloon assembly for removablysecuring the balloon assembly to the tunneling shaft, said balloonassembly including a balloon wrapped about said tunneling shaft, asheath enclosing said balloon and carried by said tunneling shaft, saidsheath having a weakened region extending longitudinally thereofpermitting said sheath to be removed to release the balloon and meansforming a balloon inflation lumen coupled to said balloon for inflatingsaid balloon to cause the balloon to progressively unwrap and attempt tolie in a plane and to expand to create separation forces in the tissuegenerally perpendicular to the plane of the balloon to create theanatomic space.
 2. An apparatus as in claim 1 together with at least onefinger ring secured to said sheath to facilitate removal of said sheath.3. An apparatus as in claim 2 together with first and second fingermembers secured to said sheath to facilitate removal of said sheath. 4.An apparatus as in claim 1 together with a first obturator slidablymounted on said tunneling shaft and having proximal and distalextremities, the distal extremity thereof having a rounded tip, saidtunneling member serving as a second obturator, said first and secondobturators being of a size so that said first and second obturators andsaid tunneling shaft can pass through said bore.
 5. An apparatus as inclaim 1 together with a handle secured to said introducer device, saidhandle being comprised of first, second and third sections, meanssecuring said first section to said tubular member, said first sectionhaving a bore therein in alignment with the bore in the tubular member,a valve member mounted in said first section and movable between firstand second position and in the first position sealing the bore in saidfirst section and in the second position permitting free access throughthe bore, latch means carried by the second section for releasablylatching said second section to said first section and latch meanscarried by the third section for releasably latching the third sectionto the second section, means securing said tunneling shaft to said thirdsection, said third section being detachable from said second section topermit retraction of the tunneling shaft to permit the tunneling membercarried by the tunneling shaft to be withdrawn and brought intoengagement with the obturator and to thereby remove the obturator fromthe tubular member of the introducer device, said obturator includingmeans for operating the latch means of the second section to cause thesecond section to be released from the first section to permit thetunneling rod and the obturator to be withdrawn at the same time fromthe introducer device solely by retraction of the tunneling rod as it iswithdrawn by movement of the third section.
 6. An apparatus as in claim5 whereby said latching means carried by the second section includes camsurfaces adapted to be engaged by the proximal extremity of theobturator as the obturator is removed by retraction of the tunnelingshaft.
 7. An apparatus as in claim 1 wherein said balloon assemblyincludes a tubular member having a flow passage therein forming aballoon inflation lumen coupled to the interior of the balloon, saidtubular member having a length so that it can extend beyond the bodywhen the apparatus is inserted into the cavity in the body to permitinflation of the balloon with a balloon inflation medium exterior of thebody.
 8. An apparatus as in claim 1 wherein said sheath is formed of arelatively flexible plastic material.
 9. An apparatus as in claim 1wherein said tunneling member is provided with a substantiallyhemispherical surface.
 10. An apparatus as in claim 1 wherein said meansfor removably securing said balloon assembly to said tunneling shaftincludes a sleeve extending longitudinally of the balloon, said sleevehaving a passage therein, said tunneling shaft being disposed in saidpassage, said sleeve having a weakened region extending longitudinallythereof permitting said balloon assembly to be removed from saidtunneling shaft by separation of the sleeve at the weakened section. 11.An apparatus as in claim 10 wherein said weakened section is formed by aplurality of longitudinally spaced apart perforations.
 12. In atunneling shaft assembly, a tunneling shaft having proximal and distalextremities, a tunneling member fixed to the distal extremity of thetunneling shaft, an obturator slidably mounted on the tunneling shaftand having proximal and distal extremities, the distal extremity havinga blunt surface and a handle section secured to the proximal extremityof the tunneling shaft.
 13. A tunneling shaft assembly as in claim 12together with releasable latch means carried by the handle section. 14.A tunneling shaft assembly as in claim 13 together with an additionalhandle section slidably mounted on the tunneling rod and having latchmeans carried thereby, said latch means having a surface adapted to beengaged by the obturator when the obturator is retracted by retractionof the tunneling shaft and the tunneling member carried thereby andengaging the obturator.
 15. In a sheath assembly for use with a hand, anelongate tubular member formed of a relatively flexible material forminga sheath, said tubular member having a weakened region extendinglongitudinally thereof, said sheath having a proximal extremity andfinger means secured to the proximal extremity of the sheath to permit afinger of the hand to engage the sheath for retraction of the same. 16.A sheath as in claim 15 wherein said finger means includes first andsecond finger rings secured to the proximal extremity of the sheath. 17.In a balloon assembly, first and second sheets of a non-elastomericmaterial, means bonding the outer margins of the sheets of material toeach other to form an enclosed space, a tubular member extending intothe balloon and having a balloon inflation lumen extending therein forintroducing a balloon inflation medium into the space for inflating theballoon to a predetermined size and shape, as determined by thenon-elastomeric material.
 18. A balloon assembly as in claim 17 whereinsaid balloon has an oval-shaped configuration.
 19. A balloon assembly asin claim 17 wherein said balloon has a rectangular configuration andwherein said tubular member is disposed along one side of said balloon.20. A balloon assembly as in claim 17 for use with a tunneling shaft andmeans carried by the balloon adapted to releasably secure said tunnelingshaft to said balloon whereby said balloon can be separated from thetunneling shaft.
 21. A balloon assembly as in claim 20 wherein saidmeans carried by the balloon for releasably securing the balloon to thetunneling shaft includes a sleeve secured to the balloon and having apassage therein through which the tunneling shaft can extend, saidsheath having a weakened region extending longitudinally thereofpermitting the balloon to be separated from the tunneling shaft bycausing the sheath to separate along the weakened region.
 22. A balloonassembly as in claim 21 wherein said weakened region is formed bylongitudinally spaced apart perforations.
 23. A balloon assembly as inclaim 21 wherein said sleeve extends longitudinally of the balloon andis spaced substantially equidistant from the side margins of theballoon.
 24. An apparatus as in claim 23 wherein said side margins ofsaid balloon are adapted to be rolled over onto the tunneling shaft. 25.A balloon assembly as in claim 24 wherein said balloon is formed into aroll together with a tubular sleeve, said roll being disposed in saidsleeve.
 26. A balloon assembly as in claim 17 wherein said balloon isrolled in one direction to form a roll.
 27. A balloon assembly as inclaim 26 together with a graft disposed on one side of the balloon andwherein the graft is rolled up with the balloon when the balloon isrolled into a roll.
 28. A balloon assembly as in claim 17 together witha hernia repair graft removably disposed on one side of the balloon. 29.A balloon assembly as in claim 28 together with means carried by theballoon for releasably retaining the graft on the balloon.
 30. A balloonassembly as in claim 29 wherein said means for releasably retaining saidgraft on said balloons includes flexible flaps overlying the sidemargins of the graft.
 31. A balloon assembly as in claim 30 wherein theouter margins of said balloon are rolled inwardly to form a pair ofrolls together with a sleeve retaining said pair of rolls in said rollconformation.
 32. In a hernia repair graft, a flexible sheet of meshmaterial, said sheet of mesh material having a central portion andtail-like means secured to the central portion and adapted to extendsubstantially perpendicular to the sheet.
 33. A hernia repair graft asin claim 32 wherein said tail is formed of a mesh material.
 34. A graftas in claim 32 wherein said tail is formed with barbs thereon.
 35. Agraft as in claim 34 wherein said tail is formed of a biodegradablematerial.
 36. A graft as in claim 35 wherein said biodegradable materialis a polyglycolic acid.
 37. A graft as in claim 32 wherein said sheet ofmaterial has side margins and wherein the side margins are rolledinwardly towards the tail to form a generally cylindrical roll.
 38. Agraft as in claim 37 together with removable sutures for retaining saidgraft in a roll.
 39. A graft as in claim 37 together with a sleeve forretaining said roll.
 40. A graft assembly as in claim 39 together with adeployment rod for deploying said roll from said sleeve.
 41. In a methodfor creating an anatomic space in tissue in a body, making an incisionin the tissue, providing a deflated balloon in a wrapped-upconfiguration and introducing the balloon through the incision and intothe tissue, progressively inflating the balloon to cause it toprogressively unwrap and to attempt to lie in a plane and to createseparation forces on the tissue generally perpendicular to the plane toform the anatomic space.
 42. A method as in claim 41 together with thestep of performing a medical procedure in the anatomic space.
 43. Amethod as in claim 42 wherein said medical procedure is a laparoscopicprocedure.
 44. In a method for laparoscopic hernia repair through thepreperitoneal space in a body having an abdominal area with an abdominalwall and a preperitoneal area underlying the abdominal wall comprisingmaking an incision in the abdominal wall into the preperitoneal area,introducing a balloon in a deflated condition into the incision and intothe preperitoneal area, inflating the balloon to create a dissectedpreperitoneal space, deflating the balloon, removing the balloon fromthe dissected preperitoneal space, inflating the dissected preperitonealspace with a gas, providing a graft in the dissected preperitoneal spaceand positioning the same so that it underlies the area of the hernia,deflating the dissected preperitoneal space to permit the graft toremain in contact with the area of the hernia in general alignment withthe hernia to provide reinforcement for the abdominal wall in the areaof the hernia.
 45. A method as in claim 44 for use in repairing aninternal hernia having a hernia sac extending through the inguinal ringof the inguinal floor and wherein the graft introduced includes asheet-like disk having a central portion and a tail secured to thecentral portion, securing the tail to the hernia sac, dissecting thehernia sac in a region which is spaced from the portion of the herniasac to which the tail is secured to provide distal and proximal portionsof the hernia sac which are separated from each other to permit the tailto be carried with the distal portion of the hernia sac through theinguinal ring, closing the proximal portion of the hernia sac, andwherein deflating the dissected preperitoneal space permits the graft tocontact the inguinal floor and be disposed between the inguinal floorand the overlying tissue.
 46. A method as in claim 44 wherein the stepof introducing a hernia graft into the dissected preperitoneal spaceincludes providing a graft with a central portion having a biodegradableanchoring tip secured thereto, positioning the graft so that the tip isin alignment with the inguinal ring and can be maneuvered into theinguinal ring for anchoring to bring the graft into contact with theinguinal floor and the overlying tissue.
 47. A method as in claim 44including the steps of providing the inflatable balloon in a roll withthe graft being disposed on one side of the balloon in the roll, andwherein the steps of providing a balloon and a graft in the dissectedpreperitoneal space is accomplished by introducing the roll into thedissected preperitoneal space and positioning the roll in the desiredlocation, inflating the balloon to cause the balloon to unroll to placethe graft in the vicinity of the hernia.
 48. A method as in claim 47including the step of providing the balloon with the graft disposedtherein in two rolls rolled inwardly towards each other and wherein theinflation of the balloon is accomplished by inflating the balloon tocause the rolls to unroll in opposite directions.
 49. A method as inclaim 47 including the step of causing the roll to unfold in onedirection as the balloon is being inflated.
 50. In a method forlaparoscopic hernia repair through the preperitoneal space of a patienthaving an abdominal area with overlying tissue and a peritoneum with apreperitoneal area being disposed between the overlying tissue and theperitoneum using laparoscopic apparatus of the type having an introducerdevice with a tubular member having a bore therein, a tunneling assemblydisposed in the bore and a balloon wrapped about the tunneling shaft anda removable sleeve enclosing the balloon, the method comprising thesteps of making an incision in the abdominal area, introducing thelaparoscopic apparatus into the incision so that the tubular member ofthe introducer device is disposed in the preperitoneal area; advancingthe tunneling rod with the balloon thereon to separate the overlyingtissue from the peritoneum, removing the sleeve to expose the balloon,inflating the balloon with a balloon inflating medium to create adissected preperitoneal space between the peritoneum and the overlyingtissue, deflating the balloon, removing the balloon, insufflating thedissected preperitoneal space with a gas, introducing a graft into thedissected preperitoneal space, positioning the graft in the desiredlocation, and deflating the preperitoneal space to permit the graft tocome into contact with tissue overlying the peritoneum, removing theintroducer device and closing the incision.
 51. A method as in claim 50together with the step of introducing the graft into the dissectedpreperitoneal space with the balloon as the balloon is introduced in thedissected preperitoneal space.
 52. A method as in claim 51 together withthe step of forming the balloon and the graft into at least one roll andwherein the balloon and the graft are introduced into the dissectedpreperitoneal space as a roll.
 53. A method as in claim 52 together withthe step of causing the balloon to unroll in a single direction as it isinflated.
 54. A method as in claim 52 wherein the balloon is unrolled infirst and second directions as the balloon is inflated.
 55. An apparatusas in claim 1 together with a tunneling member mounted on the distalextremity of the tunneling shaft.
 56. An apparatus as in claim 55wherein said tunneling member is detachably mounted on said tunnelingshaft.
 57. An apparatus as in claim 56 together with means for securingsaid detachable tunneling member to said balloon so that it can beremoved when said balloon is removed.
 58. An apparatus as in claim 57wherein said means for attaching said detachable tunneling member tosaid balloon includes a flexible elongate element having one end securedto said tunneling member and having the other end extending through theballoon.
 59. An apparatus as in claim 58 wherein said tunneling memberis provided with a bullet-shaped distal extremity and wherein said oneend of the flexible elongate element is secured centrally of thebullet-shaped distal extremity and wherein said bullet-shaped distalextremity is provided with a recess formed therein which receives saidflexible elongate element so that the flexible elongate element iswithin the confines of the bullet-shaped distal extremity and extendsfrom the distal extremity towards the balloon.
 60. An apparatus as inclaim 1 wherein said sheath enclosing said balloon is provided with adistal extremity which is substantially bullet shaped and wherein saidweakened region extends through said distal extremity.
 61. An apparatusas in claim 60 wherein said means carried by the balloon assembly forremovably securing the balloon assembly to the tunneling shaft includesa sleeve secured to said balloon, said sleeve having a weakened regionextending along the length thereof, said sleeve having at the distalextremity closing the sleeve to prevent the balloon from being separatedfrom the tunneling shaft when the sheath is separated from the balloon.